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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT00889902
Other study ID # 320.6740
Secondary ID
Status Not yet recruiting
Phase N/A
First received April 27, 2009
Last updated April 27, 2009
Start date April 2009
Est. completion date July 2011

Study information

Verified date April 2009
Source Wuhan University
Contact Hong B Cai, Doctor
Phone 0086-027-67813044
Email Chb2105@163.com
Is FDA regulated No
Health authority China: Ethics Committee
Study type Observational

Clinical Trial Summary

The purpose of this study is to:

1. make p16INK4A as a cervical cancer screening of tumor markers, cytology improve existing diagnostic sensitivity, specificity, repeatability and validity, so as to effectively prompted the early discovery and diagnosis of cervical cancer.

2. reduce screening costs, screening and benefits into quantitative evaluation, for our country to develop cervical cancer prevention and control strategy to provide a reliable theoretical basis.


Description:

1. To carry out large-scale prospective randomized controlled clinical study to evaluate the "cytological molecular markers Detect + P16INK4A" methods of screening accuracy and reliability, as well as the screening method of the biological effects.

2. Markov set up mathematical model of screening tests to quantify the inputs and the evaluation proceeds. With a view to optimize and perfect a simple, convenient, practical and efficient program of cervical cancer screening.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 200
Est. completion date July 2011
Est. primary completion date June 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 25 Years to 65 Years
Eligibility Inclusion Criteria:

- Married women aged 25 to 65-year-old with risk factors

- No tumor and pelvic radiation therapy history

- Non-pregnant women at present

Study Design

Observational Model: Case Control, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
China People'S Hospital Wufeng county Hubei

Sponsors (1)

Lead Sponsor Collaborator
Wuhan University

Country where clinical trial is conducted

China, 

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